Guidance for Completion of Afinal Report Form

GUIDANCE FOR COMPLETION OF AFINAL REPORT FORM

Institutional Review Board

Human Subjects Research

Naval Medical Center Portsmouth, VA

Contact Clinical Investigation Department at 953-5939

This is not the form. The form is a separate document which can be located on the CID SharePoint page. Please do not return this guidance document with your application.

Final reports must be submitted to the IRB to properly end the research project. A final report may be submitted to request either Completion or Closure without Completion. Final reports require review by the IRBand approval by the Commanding Officer.

REQUEST FOR COMPLETION

An investigator may request completion of their study if all study procedures have concluded. Subjects’ active participation and follow up must have ended and no further contact with subjects may occur. All data collection from medical records or hospital databases must be complete, and no IRB actions may be outstanding (such as amendments or adverse events). The investigator may continue to access the collected data for data analysis and manuscript creation, but may not re-enter medical records or hospital databases for purposes of additional data collection. To request completion, the investigator should submit a Final Report with a summary of findings and a list of planned or completed manuscripts, presentations, or abstracts.

REQUEST FOR CLOSURE-WITHOUT COMPLETION

An investigator may request closure without completion if the protocol should be closedfor lack of progress; lack of enrollment; failure to meet power for statistical analysis, lack of personnel to conduct the study (due to PCS, for example) or discovery in the literature that a similar study has been completed elsewhere and continuation would produce no additional, useful results. Data collected under a protocol that is closed without completion may not be published and all identifiable data and links to subjects must be destroyed. Signed consent forms must be sent to the Research Compliance Officer, CID and may not be retained by the PI and/or department. To request closure without completion, the investigator should submit a Final Report, indicating the intent to close and the reason for closure. The IRB may require the investigator to notify active or completed subjects of the early closure and provide information on the cause of the closure or offer guidance for continuing medical oversight as appropriate.

FINAL REPORT FORM

APPROVAL / EXPIRATION INFORMATION

Initial IRB Protocol Approval Date: Identify the date of initial IRB approval. This information is located in your initial approval package.

Initial Command Protocol Approval Date: Identify the date of CO approval. This information is located in your initial approval package.

Current Expiration Date: Identify the current study expiration date. This information is located in your initial approval package or in your previous continuing review package.

Review Cycle Periodicity: Document the length of approval. Annual? Six months? This information is located in your initial approval package or in your previous continuing review package.

Level of Review: Indicate the level of review assigned to your protocol. This information is located in your initial approval packageor in your previous continuing review package.

DISCLOSURES

Funding:

1. Does the project receive internal funding, such as from BUMED-DSG, BUMED-WII, or the Commanders Fund? Does the project receive external funding, such as from NIH,NSF, RDT&E P6, academia, or industry?
2. Is this a collaborative project? Identify if you are collaborating with any institutions or commands outside of NMCP.

1. If yes, identify the collaborating institutions. Identify the name of your collaborating institution(s).
2. Please provide the agreement number. List the agreement number. This is obtained from the Research Agreements Officer.
3. Please outline the following:

For the items below, clearly outline the scope of work for each site, and identify which activities will be done jointly (for example, data analysis, manuscript writing, etc.).

1. What activities will be done at NMCP?
2. What activities will be conducted at the collaborating institution?
3. What activities will be done jointly?

Conflict of Interest:

Do you or any other person responsible for the design, conduct or reporting of this research have an economic interest in or act as an officer or director of any outside entity whose financial interests would reasonably appear to be affected by this research? Check yes is there is an existing conflict of interest.

• If “yes”, provide a written justification for continued association with this study. If yes, justify as appropriate.

STUDY CHARACTERISTICS

Risk:

Identify the risk assessment for this protocol: Indicate if the protocol was approved as: Minimal Risk, Greater than Minimal Risk, or Greater than Minimal Risk-now eligible for review under Expedited Category 8 or 9. This information is located in your initial approval package or previous continuing review package.

FDA Regulated Protocols:

Identify the IND, IDE or HDEassociated with this protocol, if any. Indicate if this project is a Single Patient Compassionate Use.

Vulnerable Populations:

Select Vulnerable Populations being enrolled: Check Yes or No. If Yes, choose all that apply from - Newborns, Minors, Pregnant Women/Fetuses, Decisionally Impaired Adults, or Other.

Population:

Identify the subject population: Identify if your subjects are Active Duty Military members, Civilian dependents, or both. This information is located in your initial approval package or previous continuing review package.

Active Subject Recruitment?: Indicate if the protocol sought out subjects for participation, using recruitment materials such as flyers, announcements, or presentations. If yes, state if recruitment was delivered to potential subjects in a group setting. If yes, specify if an Ombudsman was present

SUMMARY OF CONSENTING / AUTHORIZATION ACTIVITY

Indicate if the study obtained consent. If yes, indicate that copies of all signed subject consent forms have been submitted to the Research Compliance Officer for review.

Indicate of this study included a Waiver of Consent or Waiver of Documentation of Consent.

Indicate if this study included a Waiver of Authorization for the Use of PHI.

SUMMARY OF STUDY ENROLLMENT

Multi-Site Enrollment Characteristics: ?

Total Approved at all Sites: Identify the total number of subjects that have been approved for enrollment across all sites.

Total Enrolled at all Sites: Identify how many subjects have been enrolled across all sites.

Most current multi-center summary report attached? Choose one.

Local Site

RECORD / SPECIMEN / SUBJECT ENROLLMENT INFORMATION

For protocols involving Records (Chart Review) or Specimens ONLY.

Total Records/Specimens IRB Approved: Identify the total number of records/specimens approved by the IRB. Be mindful that this number could have been amended since initial approval.

Total Records/Specimens Collected: Identify the total number of records/specimens collected.

Total Records/Specimens Withdrawn/Lost to Follow-Up Since Initiation: Identify the number of records/specimens withdrawn since initiation and provide a reason for why the record/specimen was not utilized.

For protocols involvingInteractions with Active Subject Participants.

Total Subjects IRB Approved: Identify the total number of subjects approved by the IRB. Be mindful that this number could have been amended since initial approval.

Total Subjects Enrolled: Identify the total number of subjects enrolled. Remember “enrolled” means the subject signed consent.

Total Subjects Withdrawn/Lost to Follow-Up: Identify the number of subjects withdrawn or lost to follow up since initiation and provide a reason for why the subjects were lost (screen failure, withdrew consent, PCSed, etc.).

Total Subjects Completed and Off Study Protocol: Identify the total number of subjects that have completed the study.

ACTIONS OR EVENTS THAT OCCURRED DURING THE REPORING PERIOD

Choose Yes or No for each item.

Indicate if any serious adverse eventsor adverse eventsoccurred during the study.

If “yes”, have they been submitted to the IRB?

Indicate if any protocol deviationsor violations occurred during the study.

If “yes”, have they been submitted to the IRB?

Indicate if any data from this study have been submitted for publication or has been presented.

If “yes”, please attach a list detailing the author(s), title, date of submission or presentation and the journal, book or society in which the manuscripts or presentations appear.

If subject consent was obtained, indicate if copies of all signed subject consent forms have been submitted to the Research Compliance Officer for review.

INVESTIGATOR REQUESTS

Completion

Describe how the study has been conducted and summarize the data results or findings.

Closure without Completion

Describe how the study has been conducted. Summarize any data results that may be available. Justify why it is appropriate to close the protocol without completion.

IMPACT ON SUBJECTS

Indicate if closure of this study may result in the potential for risks or harm to subjects.

If yes, describe the risks or harm.

Determine if subjects should be notified of the study closure.

If yes, describe how this will be accomplished.

ELECTRONIC SUBMISSION CHECKLIST

Use this checklist to make certain that all necessary documents are being included in the submission package.

APPENDIX A: SUBJECT CONSENT SUMMARY

Complete the table for each individual enrolled during this reporting period. Include a copy of this table when making the final consent form submission to the Research Compliance Officer.

Guidance for Final Report Form Completion

Version 12 September 2017Page 1